The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Tillman Hipsurface Replacement.
Device ID | K781490 |
510k Number | K781490 |
Device Name: | TILLMAN HIPSURFACE REPLACEMENT |
Classification | Prosthesis, Hip, Femoral, Resurfacing |
Applicant | WALDEMAR LINK GMBH & CO. KG 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KXA |
CFR Regulation Number | 888.3400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-08-28 |
Decision Date | 1978-09-20 |